HUM-MOLGEN events: DMCs/DSMBs

HUM-MOLGEN -> Events -> Meetings and Conferences

July 30, 2002

Barnett International, Philadelphia
October 2-3, 2002

Applying Proven Best Practices to Prevent Study Rejections and Clinical Holds

Real World Case Studies Address Common Challenges

ü Determine When and How to Implement Data Monitoring Committees (DMCs) According to Regulatory Requirements

ü Implement Strategies to Prevent Trials from Being Stopped Too Soon or Too Late

ü Analyze Practical Examples of Assuring Compliance with the Federal Regulatory Requirements

ü Optimize the Benefits of DMCs by Discovering Various Uses Including Post-Marketing Surveillance, Risk Management, and Early Phase Clinical Development

ü Expedite Interim Data Analysis to Ensure Timely Data for Timely Decisions

ü Streamline DSMBs into your Overall Organizational Scheme by Clarifying Relationships to Other Groups, Learning how to Form and Organize the DSMB

Inclusive Interactive Speaker Panel Discussion!
Examining the Issues of Independence, Blinding of Data,
and Conflicts of Interest with Experts from Various Perspectives
v How Independent Can and Should DMCs Really Be?
v Do DMCs Have Too Much, or Too Little Power?
v What Can be Done to Manage the Trade-off Between Timeliness and Quality of the Data?
v Blinded vs. Fully-unblinded vs. Partially-unblinded Interim Analyses
v Should Rules and Regulations Be Harmonized Between the Governing Bodies?

Organized by:

Justin Browne

Invited Speakers:

David E. Lilienfeld, Assoc. Director, Pharmacoepidemiology, Bristol-Myers Squibb Company

Steven M. Snapinn, Senior Director of Biostatistics, Merck Research Laboratories

Collette M. Houston, Director, Clinical Research Operations, Memorial Sloan-Kettering Cancer Center, Office of Clinical Research

Serge V. Novikov, MD PhD., Senior Product Safety Officer Global Pharmacovigilance, Aventis Pasteur, INC.

Dr. Burt Koonsvitsky, Director, Clinical Operations, B&B Clinical Innovations

Donald E. Cutlip, Chief Medical Officer, Medical Director, Harvard Clinical Research Institute

Andreas Sashegyi, Senior Statistician, Eli Lilly and Company

Michael J. Klepper, President and CEO, Integrated Safety Systems, Inc.

Phillip L.C. Banks, Corporate Director, Biostatistics, Statprobe, Inc.

Daniel F. Hayes, MD, Clinical Director, Breast Oncology Program, University of Michigan, National Cancer Institute

Keaven M. Anderson, Ph.D., Senior Director, Centocor

Stephen P. Heyse, M.D., M.P.H., Medical Officer, Office of Clinical Research Affairs, Division of Microbiology and Infectious Diseases, NIAID, NIH

Roger J. Lewis, MD, PhD, Director of Research Associate Professor of Medicine, Harbor-UCLA Medical Center, Department of Emergency Medicine

Joanna Haas MD MSc, Senior Medical Director, Genzyme

Jules T. Mitchel, President, Target Health Inc.

Deadline for Abstracts:

passed

Registration:

215-492-9000

E-mail:

lisa.zoks@parexel.com

Posted by:

justin brown

Host:

24-90-9-192.si.rr.com